DenMat gets FDA clearance for clear aligners

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to DenMat for the right to design, manufacture, and sell orthodontic clear aligners to dental professionals and laboratories.

DenMat's OrthoClear aligners are intended to be a cost-effective, dentist-supervised alternative to the recent wave of do-it-yourself orthodontic aligners, the company said.

Production of the OrthoClear aligners involves a 3D virtual treatment plan that clinicians can use to review tooth movement and anticipate outcomes before generating the personalized aligners. The turnaround time for production and delivery of the custom clear aligners is roughly five days, according to the company.

The OrthoClear orthodontic aligners. Image courtesy of DenMat.